UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011762 |
|---|---|
| Receipt number | R000013755 |
| Scientific Title | Validation of Japanese version of BESTest and Mini-BESTest for balance assessments |
| Date of disclosure of the study information | 2013/09/14 |
| Last modified on | 2014/04/13 21:47:12 |
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Basic information
Public title
Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Acronym
Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Scientific Title
Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Scientific Title:Acronym
Validation of Japanese version of BESTest and Mini-BESTest for balance assessments
Region
| Japan |
Condition
Condition
Patients with balance disorders and healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To translate BESTest and Mini-BESTest, newly developed balance function assessment sets, into Japanese and evaluate those validity
Basic objectives2
Others
Basic objectives -Others
Validation study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Japanese version of BESTest or Mini-BESTest and other well-known balance measures (Berg Balance Scale, Activities-specific balance confidence scale and Falls Efficacy Scale International)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Patients>
With a neurological or musculoskeletal condition ( cerebrovascular diseases, neuromuscular diseases, hip fracture, osteoporosis)
Able to ambulate 6m without human assistance
Able to follow 3-step commands
Able to understand commands in BESTest or Mini-BESTest
Consent to participate in this study
<Healthy adults>
No past history of neurological and/or musculoskeletal diseases
Consent to participate in this study
Key exclusion criteria
With excessive fatigue or pain during the balance tasks
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eri Otaka |
Organization
Eisei Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
583-15 Kunugida-chou, Hachiouji, Tokyo, Japan
TEL
0426-61-4108
eyokohama93@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eri Otaka |
Organization
Eisei Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
583-15 Kunugida-chou, Hachiouji, Tokyo, Japan
TEL
0426-61-4108
Homepage URL
eyokohama93@gmail.com
Sponsor or person
Institute
Eisei Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Rehabilitation Medicine, Keio University School of Medicine
Keiyu Orthopaedic Hospital
NHO Higashisaitama Hospital
Tokyo Bay Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
永生病院（東京都）、慶友整形外科病院（群馬県）、国立病院機構東埼玉病院（埼玉県）、東京湾岸リハビリテーション病院（千葉県）
Eisei Hospital
Keiyu Orthopedic Hospital
NHO Higashisaitama Hospital
Tokyo Bay Rehabilitation Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 03 | Month | 15 | Day |
Other
Other related information
To explore whether there are good correlation between BESTest or Mini-BESTest and other well-known balance measures (Berg Balance Scale, Activities-specific balance confidence scale and Falls Efficacy Scale International).
Management information
Registered date
| 2013 | Year | 09 | Month | 13 | Day |
Last modified on
| 2014 | Year | 04 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013755
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
